Recruiting

Wearable Technology

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06124196

Conditions

Duchenne Muscular Dystrophy

Eligibility Criteria

Sex: Male

Age: 10+

Healthy Volunteers: Accepted

Interventions

wearable technology

Study Details

Brief summary:

Duchenne muscular dystrophy (DMD) is an X-linked disorder that causes muscle wasting, cardiopulmonary failure, and premature death. Heart failure is a leading cause of death in DMD, but substantial knowledge gaps exist regarding predisposing risk factors. In the general population, hyperglycemia, insulin resistance, and decreased heart rate variability (HRV; reflecting autonomic dysfunction) are associated with cardiomyopathy (CM). It is unclear whether these factors are associated with DMD-CM. Closing this knowledge gap may lead to novel screening and therapeutic strategies to delay progression of DMD-CM, now the leading cause of death in patients with DMD. Despite risk factors for hyperglycemia, including the use of glucocorticoids (GCs), sarcopenia, obesity, and reduced ambulation, little is known regarding glucose abnormalities in DMD. Some of these same risk factors, along with the distance needed to travel for specialty care, present significant barriers to research participation and clinical care for individuals with DMD. Remote wearable technology may improve research participation in this vulnerable population. Therefore, this study will leverage remote wearable technologies to overcome these barriers and define the relationship between dysglycemia and DMD-CM.

The goal of this remote study is to evaluate rates of hyperglycemia in individuals with DMD compared to control participants using continuous glucose monitors, and to determine the relationship between hyperglycemia and heart rate variability. Participants will utilize continuous glucose monitors, cardiac monitors, and activity monitors to evaluate glucose levels, heart rate, activity, and sleep.

Conditions

Duchenne Muscular Dystrophy

Study ID

NCT06124196

Start date

Mar 20, 2024

Status verified date

May, 2026

Completion date

Feb, 2031

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 10+

Healthy Volunteers: Accepted

CASE, DMD inclusion criteria:

  • Male
  • Age ≥10years
  • Clinical phenotype of DMD confirmed with muscle biopsy or genotype.
  • Informed consent for individuals ≥18 years
  • Parent/guardian informed consent and child assent for individuals < 18 years

CASE, DMD exclusion criteria:

  • Refusal to participate.
  • Diagnosis of diabetes prior to the study and/or taking insulin or other anti-diabetic drug therapy in < 4 weeks prior to treatment
  • Use of a pacemaker, Implantable cardioverter-defibrillator (ICD), or other implanted device
  • Unable to comply with study procedures, in the opinion of the investigator.

CONTROL inclusion criteria:

  • Male
  • Age ≥10years
  • Informed consent for individuals ≥18 years
  • Parent/guardian informed consent and child assent for individuals < 18 years
  • BMI matched by Centers for Disease Control and Prevention (CDC) category (underweight, normal, overweight, obese) to cases.
  • Self-reported race/ethnicity matched to cases.
  • No known evidence of diabetes, impaired fasting glucose, or impaired glucose tolerance:
  • For individuals (all ≥10 years) of age with obesity, we anticipate that they will have hemoglobin A1c (HbA1c) screening based on American Academy of Pediatrics (AAP) recommendations.
  • Participants will be included if they have a normal HbA1c (< 5.7%) or if they have an elevated HbA1c (5.7-6.4%) with no evidence of impaired fasting glucose or impaired glucose tolerance on clinically obtained oral glucose tolerance tests (OGTT) (e.g., fasting glucose <100mg/dL and 2-hour glucose <140mg/dL).

CONTROL, exclusion criteria:

  • Refusal to participate.
  • Diagnosis of diabetes prior to the study and/or taking insulin or other anti-diabetic drug therapy in < 4 weeks prior to treatment
  • Use of a pacemaker, Implantable cardioverter-defibrillator (ICD), or other implanted device
  • Unable to comply with study procedures, in the opinion of the investigator.
  • Diagnosis of DMD or Becker muscular dystrophy

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Case - DMD

40 male individuals with DMD

Controls

40 matched controls (gender, age ± 1 year, BMI category, self-reported race/ethnicity).

Interventions

wearable technology

Three wearable devices

Primary outcome measure

  • Rate of hyperglycemia [ Time Frame: once over 10 days ]
  • Standard deviation of the mean R-to-R segment (SDANN) [ Time Frame: once over 7 days ]

Central Contacts and Locations

Central contacts

Jaclyn Tamaroff, MD

615-875-7853Jaclyn.tamaroff@vumc.org

Andrea Lee, MA, MLS

615-875-9602Andrea.e.lee@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Jaclyn Tamaroff, MD

615-875-7853Jaclyn.tamaroff@vumc.org

Andrea Lee, MA, MLS

615-875-9602Andrea.e.lee@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Duchenne Muscular Dystrophy
  • heart failure
  • cardiomyopathy
  • hyperglycemia
  • heart rate variability
  • remote
  • controls

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-22.